Shaun Sweeney @ STEM Recruitment is working with our client for a unique opportunity that has been created to join their Quality Control team as a GMP Technical Writer. You will be responsible for managing and maintaining all documentation as it relates to GMP production and Quality Control including the creation and updating of all records including Manufacturing Procedures, Standard Operating Procedures, Validation Protocols and Summary Reports, Non-conformance Reports, CAPAs, CCRs, and more.
Apply on Partner Site
Key responsibilities include:
* Author and revise GMP documents
* Prepare, review, revise, and maintain technical documents including Standard Operating Procedures, Manufacturing Procedures, Non-conformance Reports, CAPAs, Effectiveness Checks, Change Controls, Risk Assessments, Summary Reports
* Write, format, edit, and summarise procedural and technical information for technical and non-technical users
* Coordinate interdepartmental review of documents and track revision history utilising the document management system
* Gather and analyse technical and product information from various sources to document new or changing product functionality
* Interview operators and Subject Matter Experts and participate in processes as needed to gain adequate understanding of the manufacturing process and associated systems
* Assist in planning, scheduling, and tracking documentation work to meet product release dates in a dynamic environment.
* Implement strategies in helping to build a GMP culture
* Identify and incorporate relevant analytical data in support of product investigations
* Must hold a bachelor’s degree
* Work closely with SMEs, process owners, and Quality representative to produce accurate, compliant, and unambiguous operating procedures
* Assist in executing change controls where needed
* Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience
* Must be detailed oriented, able to multi-task and possess excellent time management and organisational skills
* Must be able to relate to employees at all levels of the organisational structure
* Experience in creating documentation for audiences with different levels of technical skill
* Excellent writing, editing, and communication skills
* Required: 2 years of experience working in a GMP regulated environment and knowledge of GMP regulations
* Preferred: 3-5 years of experience working in a GMP manufacturing environment contributing to process development
* Must be able to communicate tactfully and effectively
* Must have intermediate to advanced proficiency in the MS Office suite, including but not limited to Word, Excel, and PowerPoint.
Please apply online in the first instance.
STEM Recruitment Solutions Ltd operates as a recruitment agency in this instance. We endeavour to reply to all applications when possible
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